ChiCTR2200056996 版本V1.6 版本创建时间2022/10/26 00:09:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200056996 

最近更新日期：

Date of Last Refreshed on：

 2022-10-25 23:58:12 

注册时间：

Date of Registration：

 2022-02-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

随机、开放、两周期、自身交叉对照设计，采用葡萄糖钳夹技术评价空腹状态下德谷胰岛素注射液与“诺和达”在中国健康成年男性受试者中药效学和安全性比对试验

Public title：

A randomized, open, two-period, self-cross-control design, using glucose clamp technology to evaluate pharmacodynamics and safety of insulin degludec injection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

随机、开放、两周期、自身交叉对照设计，采用葡萄糖钳夹技术评价空腹状态下德谷胰岛素注射液与“诺和达”在中国健康成年男性受试者中药效学和安全性比对试验

Scientific title：

A randomized, open, two-period, self-cross-control design, using glucose clamp technology to evaluate pharmacodynamics and safety of insulin degludec injection

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘献芳 

研究负责人：

郭风雪 

Applicant：

Liu Xianfang 

Study leader：

Gou Fengxue 

申请注册联系人电话：

Applicant telephone：

 +86 18632096620

研究负责人电话：

Study leader's
telephone：

+86 17731998618

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 1511494359@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 gfx0266@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

邢台市信都区钢铁北路618号

研究负责人通讯地址：

河北省邢台市信都区钢铁北路618号

Applicant address：

618 Iron and Steel Road North, Xindu District, Xingtai, Hebei, China

Study leader's address：

618 Iron and Steel Road North, Xindu District, Xingtai, Hebei, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

邢台医专第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Xingtai Medical College

研究负责人所在单位：

邢台医专第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Xingtai Medical College

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 XYEYCTEC-HS-063

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

邢台医专第二附属医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of the Second Affiliated Hospital of Xingtai Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-09-17 00:00:00

伦理委员会联系人：

柳振芳

Contact Name of the ethic committee：

Liu Zhenfang

伦理委员会联系地址：

河北省邢台市信都区钢铁北路618号

Contact Address of the ethic committee：

618 Iron and Steel Road North, Xindu District, Xingtai, Hebei, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

邢台医专第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Xingtai Medical College

研究实施负责（组长）单位地址：

河北省邢台市信都区钢铁北路618号

Primary sponsor's address：

618 Iron and Steel Road North, Xindu District, Xingtai, Hebei, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

珠海

Country：

China

Province：

Guangdong

City：

Zhuhai

单位(医院)：

珠海联邦制药股份有限公司

具体地址：

金湾区三灶镇安基路2428号

Institution
hospital：

Zhuhai United Laboratories Co.

Address：

2428 Anji Road, Sanzao Town, Jinwan District

经费或物资来源：

珠海联邦制药股份有限公司

Source(s) of funding：

Zhuhai United Laboratories Co.

研究疾病：

用于治疗成人2型糖尿病  

Target disease：

For the treatment of adult type 2 diabetes

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要目的：比较中国健康成年男性受试者单次皮下注射德谷胰岛素注射液（受试制剂）与原研产品诺和达（参比制剂）的药效学相似性。 次要目的：评价德谷胰岛素注射液的安全性；初步评价德谷胰岛素的免疫原性。  

Objectives of Study：

Main purpose: To investigate the pharmacokinetic characteristics of insulin degludec injection, and compare the effects of single subcutaneous injection of insulin degludec injection (test preparation) and original product Novota (reference preparation) in Chinese healthy adult male subjects pharmacokinetic similarity. Secondary objectives: 1. To evaluate the pharmacodynamic properties of insulin deglucol injection; 2. To evaluate the safety of insulin deglucol injection; to preliminarily evaluate the immunogenicity of insulin deglucol.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 性别：男性；
2. 年龄：年龄为18-45岁（含临界值）；
3. 研究者判断拟注射试验用药品腹壁部位的皮肤正常，无脂肪增生、皮肤凹陷、皮肤硬结、瘢痕、炎症、水肿、溃疡、感染、出血等情况；
4. 糖耐量正常（空腹血糖[FPG] ＞3.9 mmol/L且< 6.1 mmol/L，且葡萄糖耐量试验（OGTT）2小时血糖< 7.8 mmol/L，糖化血红蛋白值<6.0%）；
5. 胰岛素分泌功能正常（通过胰岛素释放试验（IRT）证实）；
6. 胰岛素抗体阴性；
7. 体重≥50.0kg，体重指数（BMI）在19.0-24.0 kg/m2之间（BMI=体重（kg）/身高2（m2）），包括临界值；
8. 受试者理解并遵守试验流程，自愿参加研究并签署书面的知情同意书。

Inclusion criteria

1. Gender: male;
2. Age: 18-45 years (including the critical value);
3. The investigator judged that the skin of the abdominal wall of the drug to be injected was normal, without fat hyperplasia, skin depression, skin induration, scar, etc. Inflammation, edema, ulcer, infection, bleeding, etc.;
4. Normal glucose tolerance (fasting blood glucose (FPG) > 3.9 mmol/L and < 6.1 mmol/L, and glucose tolerance test (OGTT) 2-hour blood glucose < 7.8 mmol/L , glycated hemoglobin value < 6.0%);
5. Normal insulin secretion function (confirmed by insulin release test (IRT));
6. Insulin antibody negative;
7. Body weight >= 50.0 kg, body mass index (BMI) between 19.0-24.0 kg/m2 (BMI = weight (kg)/height2 (m2)), including the critical value;
8. The subjects understand and comply with the experimental procedures, voluntarily participate in the research and sign the written informed consent.

排除标准：

1. 明确的对本研究用所有药物或其制剂成分过敏者；
2. 有药物过敏或食物过敏或对饮食有特殊要求、过敏性疾患史或过敏体质者；
3. 具有糖尿病家族史（一级亲属内，即父母或兄弟姐妹或子女）；
4. 具有严重低血糖发作病史；
5. 具有晕厥或黑曚病史；
6. 经研究者判断具有任何临床显著的既往或现患心血管、内分泌、代谢性、肺部、胃肠、肝脏、肾脏、血液系统、免疫系统、神经系统疾病、精神障碍等疾病，可能影响药物吸收、分布、代谢、排泄或安全性评估或可能使依从性降低；
7. 试验前实验室检查（血常规、尿常规、血生化、凝血功能）异常且有临床意义者；
8. 筛选时乙型肝炎表面抗原阳性，或丙型肝炎抗体或梅毒特异性抗体或艾滋病抗体检测结果异常有临床意义者；
9. 心电图检查或生命体征（体温、脉搏、血压）异常有临床意义者（体温<35.7℃或＞37.5℃；脉搏<60次/分或>100次/分；收缩压<90 mmHg或>139 mmHg，舒张压<60 mmHg或>89 mmHg；）；
10. 筛选前6个月内接受过任何手术者；
11. 筛选前3个月内失血或献血超过400 mL，或接受过血液或血液成份输注者；
12. 筛选前3个月内参加过任何药物或医疗器械的临床试验且给药者（含安慰剂组），以末次服药时间计算；
13. 筛选前1个月内接种过任何疫苗者；
14. 在服用本研究用药前1个月内服用了任何药物，包括处方药、非处方药和草药；
15. 既往有药物滥用史，或尿药筛查阳性者；
16. 首次给药前3个月内每日吸烟超过5支香烟或等量烟草的或者试验期间不能戒烟者；
17. 首次给药前28天内每周饮酒超过14杯（1杯=5盎司（150mL）葡萄酒=12盎司（360mL）啤酒=1.5盎司（45mL）烈酒），或首次给药前48小时内服用过任何含酒精的制品，或酒精呼气试验＞0.0mg/100mL者；
18. 首次给药前14天内饮用过量（一天8杯以上，1杯=200 mL）茶、咖啡或含咖啡因的饮料，或食用葡萄柚（西柚）、或富含黄嘌呤的食物或饮料者，或给药前48小时内及试验期间不能停止食用富含黄嘌呤成分的食物或饮料（如巧克力、茶、咖啡及可乐等）、或葡萄柚（西柚）或柚子以及含葡萄柚或柚子成分的产品（西柚汁、柚子汁等）者；
19. 首次给药前3天及参加研究期间仍需或计划从事剧烈体力活动或运动者；
20. 受试者（或其伴侣）在给药前2周至研究结束后3个月内有妊娠计划，不愿采取适当的避孕措施者；
21. 不能耐受静脉穿刺者，采血困难、有晕针、晕血史或经研究者评估不能建立充分的静脉通道者；
22. 研究者认为不适合参加临床试验的其他情况。

Exclusion criteria：

1. Patients who are definitely allergic to all drugs or their preparations used in this study;
2. Patients with drug allergy or food allergy or special dietary requirements, history of allergic diseases or allergic constitution;
3. Patients with family history of diabetes (first degree relatives, namely parents or siblings or children);
4. Patients with history of severe hypoglycemia;
5. Patients with history of syncope or blackness;
6. Patients with cardiovascular, endocrine, metabolic, lung, gastrointestinal, liver, kidney, blood system, immune system, nervous system diseases, mental disorders and other diseases that are clinically significant may affect drug absorption, distribution, metabolism, excretion or safety assessment, or may reduce compliance;
7. Patients with abnormal laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function) and clinical significance before the trial;
8. Screening for hepatitis B surface antigen positive patients, or hepatitis C antibody or syphilis specific antibody or AIDS antibody test results are abnormal clinical significance;
9. Patients with abnormal ECG or vital signs (body temperature, pulse, blood pressure) and clinical significance (body temperature < 35.7 degrees C or > 37.5 degrees C); Pulse < 60 beats/min or > 100 beats/min; Systolic blood pressure < 90 mmHg or > 139 mmHg, diastolic blood pressure < 60 mmHg or > 89 mmHg;
10. The patients who had undergone any operation in the first 6 months were screened;
11. The patients who lost blood or donated more than 400 mL blood in the first 3 months, or who received blood or blood component infusion;
12. Patients (including placebo group) who have participated in any clinical trials of drugs or medical devices within 3 months before screening were calculated according to the last medication time;
13. The subjects who had received any vaccine within one month before screening;
14. Subjects who took any drugs within one month before taking the drugs in this study, including prescription drugs, over-the-counter drugs and herbal medicines;
15. Subjects with previous drug abuse history or positive urine drug screening;
16. Subjects who smoked more than 5 cigarettes or the same amount of tobacco per day within 3 months before the first administration or who could not quit smoking during the trial period;
17. Subjects who drank more than 14 cups per week within 28 days before the first administration (1 cup = 5 ounces (150 mL) of wine = 12 ounces (360 mL) of beer = 1.5 ounces (45 mL) of spirits), or took any alcoholic products within 48 hours before the first administration, or whose alcohol breath test was more than 0.0 mg/100mL;
18. Those who drink too much tea, coffee or caffeinated beverage (more than 8 cups per day, 1 cup = 200 mL) 14 days before the first administration, or eat grapefruit (grapefruit), or food or beverage rich in xanthine, or cannot stop eating food or beverage rich in xanthine (such as chocolate, tea, coffee, cola, etc.) 48 hours before administration and during the trial period or grapefruit (grapefruit) or grapefruit, and products containing grapefruit or grapefruit components (grapefruit juice, grapefruit juice, etc.);
19. Subjects who still need or plan to engage in strenuous physical activity or exercise 3 days before the first administration and during the study period;
20. Subjects (or their partners) have pregnancy plans from 2 weeks before administration to 3 months after the end of the study and are unwilling to take appropriate contraceptive measures;
21. Subjects who could not tolerate venipuncture, had difficulty in blood collection, had a history of needle syncope or blood syncope, or could not establish adequate venous access according to the evaluation of the researchers;
22. The investigator believes that it is not suitable to participate in other situations of clinical trials.

研究实施时间：

Study execute time：

从 From 2022-02-14 00:00:00至 To 2022-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-14 00:00:00 至 To 2022-04-01 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 19

Group：

Group A

Sample size：

干预措施：

受试制剂/参比制剂

干预措施代码：

Intervention：

TR

Intervention code：

组别：

B组

样本量：

 19

Group：

Group B

Sample size：

干预措施：

参比制剂/受试制剂

干预措施代码：

Intervention：

RT

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 邢台医专第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Xingtai Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

葡萄糖输注率(GIR)曲线下面积0-24小时

指标类型：

主要指标

Outcome：

area under the glucose infusion rate (GIR) curve 0-24 h, AUCGIR, 0-24h

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试制剂和参比制剂发生的不良事件

指标类型：

次要指标

Outcome：

Adverse events of tested and reference preparations (hypoglycemic events, allergic reactions and so on)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试制剂和参比制剂不良事件发生率

指标类型：

次要指标

Outcome：

Incidence of adverse events of test and reference preparations

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

试验前后受试者体格检查

指标类型：

次要指标

Outcome：

Physical examination of subjects before and after the trial

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

试验前后受试者各项实验室检查（血常规、血生化、胰岛素抗体等）值的变化

指标类型：

次要指标

Outcome：

Changes of laboratory tests (blood routine, blood biochemistry, insulin antibody, etc.) before and after the test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

随机分组表由数据管理和统计分析单位使用SAS 9.4（或以上版本）统计学软件产生。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random grouping table is generated by the data management and statistical analysis unit using SAS 9.4 (or above) statistical software.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

邢台医专第二附属医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The Second Affiliated Hospital of Xingtai Medical College

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

电子病例报告表（eCRF）：数据管理员根据试验方案设计构建，并根据逻辑核查计划（DVP）设置逻辑核查，通过测试并获申办方批准后发布使用。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic case report form (eCRF): The data manager is designed and constructed according to the trial plan, and set up a logical verification according to the logical verification plan (DVP), and will be released for use after passing the test and being approved by the sponsor.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-02-25 16:03:37